Manager Oral Solid Dosage (Mfg & Packaging)
About The Position
The Oral Solid Dosage (OSD) Manager is a key operational leader responsible for overseeing all aspects of oral solid dose manufacturing and packaging operations and providing strategic and operational (tactical) leadership within a cGMP-compliant pharmaceutical contract development and manufacturing organization (CDMO). This includes dispensing, granulation, compression, encapsulation, coating, and primary and secondary packaging. Products are a mix of branded and Gx and types of OSD/liquid dosage forms across many therapeutic areas. This role ensures operational excellence, optimal capacity utilization, regulatory compliance, and delivery performance while maintaining a strong focus on safety, quality, cost, and customer satisfaction. The position requires a highly technical and operational leader capable of understanding and assisting with equipment qualification and process validation , leading complex investigations, implementing continuous improvement initiatives, and managing cross-functional capital and operational projects. The OSD Manager serves as a critical link between front-line operations and senior leadership, reporting to the Director of Operations. They will have up to 6 direct reports. This position is 100% on site at 30 North Jefferson Road, Whippany, NJ.
Requirements
- Bachelor’s degree in engineering, Pharmaceutical Sciences, or related technical field required.
- Minimum 10–15 years’ experience in pharmaceutical manufacturing.
- Minimum 7–10 years leadership experience in Oral Solid Dosage manufacturing and packaging.
- Strong working knowledge of FDA 21 CFR Parts 210/211, ICH guidelines, and applicable regulatory standards.
- Strong analytical thinking. Excellent communication (written and verbal) skills. Strong organizational skills.
Nice To Haves
- master’s degree preferred.
- Lean Six Sigma Green Belt or equivalent, Black Belt strongly preferred
- PMP (Project Management Professional) certification strongly preferred
- Experience in CDMO environment strongly preferred. Ability to work in fast-paced regulated environment. Proven track record of leading teams through regulatory inspections and audits.
- Demonstrated experience with equipment qualification and validation (IQ/OQ/PQ/PV).
- Experience leading deviation investigations and CAPA.
- Strong experience in capacity planning and utilization optimization.
- Experience with controlled substance manufacturing (DEA Schedule I–V) is a plus.
Responsibilities
- Lead and manage all OSD manufacturing and packaging operations to ensure safe, compliant, and efficient production. Ensure departments meet production schedules, customer delivery commitments, and financial targets.
- Develop and manage capacity models and utilization plans to optimize throughput, efficiency, and asset performance. Manage departmental budgets and control operational costs. Support strategic capacity expansion and capital investment planning.
- Collaborate with Supply Chain and Production Planning to align capacity with demand forecasts. Ensure operational readiness including staffing, training, and equipment availability.
- Maintain Tier boards and drive KPI performance visibility. Establish performance goals and conduct performance reviews aligned to strategic direction.
- Lead and execute capital projects, process improvement projects, and operational initiatives. Develop project timelines, budgets, and deliverables. Coordinate cross-functional project teams and participate in client project meetings, providing operational expertise and representing manufacturing and packaging capabilities.
- Actively contributes to the development and revision of SOPs, work instructions, and training materials to reflect best practices and regulatory updates.
- Lead, mentor, and develop a team of Manufacturing and Packaging Supervisors, engineers and production personnel, fostering a culture of accountability, continuous improvement, and operational excellence.
- Support business development efforts by providing technical input for proposals, client tours, and capability assessments
- Drive Operational Excellence initiatives utilizing Lean Manufacturing, Six Sigma, and Continuous Improvement methodologies.
- Lead productivity improvement, waste reduction, cycle time reduction, and OEE improvement programs.
- Serve as a change agent promoting a culture of operational excellence and continuous improvement.
- Lead root cause investigations and implement effective CAPAs.
- Provide technical leadership for manufacturing and packaging processes.
- Lead and/or support execution of Equipment commissioning, Equipment Qualification (IQ/OQ/PQ, Validation lifecycle, Process Validation (PV):
- Support technical transfers, scale-up, and process optimization.
- Provide hands-on technical troubleshooting and problem solving.
- Extensive knowledge of Oral Solid Dosage processes (ie. Granulation, compression, encapsulation, coating and primary/secondary packaging)
- Capacity planning and operational analytics
- Ensure full compliance with cGMP, FDA, and other applicable international regulatory requirements. Partner with Quality Assurance to ensure audit readiness and regulatory inspection success.
- Lead and approve deviation investigations, root cause analysis (Fishbone/5-why/FMEA), and CAPA implementation.
- Review and approve batch records, deviation reports, change controls, CAPAs, and other GMP documentation in a timely and accurate manner.
- Ensure compliance with safety policies and procedures. Lead safety initiatives and behavioral-based safety programs.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
